Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Asthma and Obesity Specific Quality of Life
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.
详细描述
This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force (USPSTF) and American Academy of Pediatrics (AAP) guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria:
- •Inclusion criteria
- •Age 4-17.9 years at time of screening
- •BMI ≥ 85th percentile
- •Asthma or reactive airway disease diagnosis, per child's Electronic Health Record (EHR) documentation and caregiver report
排除标准
- •Diagnosis of anorexia nervosa, per child's EHR or caregiver report
- •Pregnant, per child's EHR
- •Plan to change pediatricians in the next year, per caregiver report
- •Opted out of research, per child's EHR
- •Sibling currently enrolled in the research trial, per enrollment log or caregiver report
研究组 & 干预措施
CHAMPION via Telehealth
- Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual)
- Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month
干预措施: CHAMPION (Behavioral)
CHAMPION via In-Person
- Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person)
- Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month
干预措施: CHAMPION (Behavioral)
结局指标
主要结局
Change in Asthma and Obesity Specific Quality of Life
时间窗: 0-12 months
Per response to caregiver-proxy survey
Change in Child Body Mass Index (BMI)
时间窗: 0-12 months
Measured as BMI based on child height and weight
Change in Asthma Control Test
时间窗: 0-12 months
Per Asthma Control Test
Change in Child BMI z-score
时间窗: 0-12 months
Measured as BMI based on child height and weight, and derived from Centers for Disease Control and Prevention (CDC) growth curves accounting for child age and sex
次要结局
- Asthma-related healthcare utilization(0-12 months)
- Change in Child Diet Quality(0-12 months)
- Change in disordered eating symptoms(0-12 months)
- Change in Child Average Hours of Sleep(0-12 months)
- Family-centered care assessment(12 months)
- Telehealth satisfaction(12 months)
- Change in Child Average Days of Physical Activity(0-12 months)
- Change in Child Average Hours of Screen Time(0-12 months)
- Change in perceived stress (caregiver)(0-12 months)
- Barriers to program attendance(12 months)
研究者
Lauren G. Fiechtner, M.D.
Assistant Professor of Pediatrics
Massachusetts General Hospital